Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: donepezil hydrochloride

• Registration Number: NCT01129596
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to investigate the following about donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease in clinical practice: cognitive function, Functional Assessment Staging (FAST) score, adverse events/adverse drug reactions, and patient background.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Study Start: 2010-06-10
• Primary Completion: 2015-09-25
• Study Completion: 2016-06-23
• Status Verified: 2017-01
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	donepezil hydrochloride	-

Primary Outcome Measures

Name	Time	Method
The transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiation	48 months(12 weeks and every 6 months)